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FDA Recommends New Guidelines for Acetaminophen Prescriptions

The Food and Drug Administration has recommended new protocols for physicians prescribing medications that contain the drug acetaminophen.

The agency said in January that doctors should no longer advise patients to take prescriptions that have at least 325 mg of the drug, save for special circumstances when two tablets or two capsules totaling no more than 650 mg of acetaminophen are needed.

“FDA is recommending health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 milligrams of acetaminophen per tablet, capsule, or other dosage unit,” the agency said in a statement. “There are no available data to show that taking more than 325 mg of acetaminophen per dosage unit provides additional benefit that outweighs the added risks for liver injury.”

“Further, limiting the amount of acetaminophen per dosage unit will reduce the risk of severe liver injury from inadvertent acetaminophen overdose, which can lead to liver failure, liver transplant, and death,” the FDA said.

According to the Mayo Clinic, acetaminophen is contained in many over-the-counter and prescription drugs such as Tylenol, Exedrin, Children’s Nortemp, Feverall, and heavier substances such as Lortab and Vicodin HP. The drug provides pain and fever relief, but does little to reduce swelling and redness, according to the Mayo Clinic.

Overdosing on the drug is a serious concern when prescriptions or over-the-counter recommendations for use are not followed correctly, the effects of which could lead to vomiting, stomach pains, and liver damage.

Aside from largely discontinuing the use of prescriptions with more than 325 mg of acetaminophen, the FDA also advised pharmacists to be more vigilant in filling prescriptions that go against the recommendation. If a prescription is found to have more than 325 mg of acetaminophen, pharmacists are asked to confer with health care professionals about lowering the patient’s dosage.